Monitoring of Postprandial Glycemic Variability in Healthy Young Infants (IGVM)

Lausanne University Hospital (CHUV)

Status: Completed

Conditions: Infant Conditions; Glucose Intolerance

Treatments: Device: Glucose monitoring

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03819725

CER-VD / 2017-02090

Details and patient eligibility

About

To measure and quantify the postprandial glucose variations in response to a meal in the healthy 6-12 months old child and correlate this response with the composition of this meal.

Full description

14 full-term infants (boys and girls) aged six to twelve months and fed a diversified diet including infant formula, solid foods such as mixed meat and vegetable preparation or marketed preparations will be recruited. Children will be recruited in the Lausanne Childrens hospital and only be included in the study whenin good general health.

FreeStyle® Libre Pro Interstitial Glucose Meter will be applied on the last day before discharge from the hospital after skin preparation with anesthetic cream (Emla®) during hospitalization and measurements will be recorded during 2-5 days.

It is not intended to measure capillary or venous blood glucose levels during this study. However, if blood is collected during hospitalization, blood glucose will be measured in parallel with the interstitial glucose measured with the device.

The child will follow his usual diet without modifications. The amount of food consumed by the child as well as the length of the meals will be recorded by the parents. For meals made by the parents they will be asked to keep a sample not seen to analyze their carbohydrate content. The total carbohydrate content will be measured .

Enrollment: 10 patients

Sex: All

Ages: 6 to 12 months old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Term infants (boys and girls)
• 6 to 12 months old
• In good general health
• Nourished with diverse nutrition including infant formula, solid foods such as mixed meat and vegetable preparation or marketed preparations
• Infant child: if the child is breastfed partially, it can be included in the study. In this case, only samples of a food supplement will be collected for evaluation of the composition.
• Hospitalized at the Lausanne Children's Hospital for non-severe reasons that do not affect or suspect to affect glucose metabolism
• Measures of feeding (time and compositions with samples) feasible for 3 consecutive days by the parents at home

Exclusion criteria

• Child born premature
• One or both parents with type 2 diabetes or gestational diabetes
• Child totally breastfed
• Chronic skin condition such as eczema, excessive dryness.
• Allergy known to adhesive plaster
• Infectious diseases affecting the skin (eg chickenpox, scarlet fever,)
• disorders of cutaneous microcirculation
• Infants suffering from diseases affecting nutrition or digestion (diarrheal gastroenteritis) and children undergoing antibiotic treatment that may affect gastrointestinal absorption
• Magnetic Resonance Imaging (MRI), Computed Tomography (CT), or Diathermy Therapy

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Glucose monitoring

Other group

Description:

FreeStyle® Libre Pro Interstitial Glucose Meter will be applied after skin preparation with anesthetic cream (Emla® ) and glucose measurements will be monitored during 2-5 days. Oral food intake will be recorded.

Treatment:

Device: Glucose monitoring